Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)
H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of the study is to refine, finalize, implement, and evaluate a multi-level intervention aimed at increasing enrollment of Black and Hispanic patients to National Cancer Institute (NCI)-sponsored therapeutic clinic trials at Moffitt Cancer Center.
Description
A stratified cluster randomized design will be used to assess the impact of the Advancing Clinical Trials: Working through Outreach, Navigation, and Digitally Enabled Referral and Recruitment Strategies (ACT WONDER²S) multi-level intervention on increasing referral and enrollment to NCI-sponsored therapeutic clinical trials among Black and Hispanic patients. Geospatial analytics were used to identify clusters of census tracts within the Moffitt catchment area ("priority zones") with high Black and Hispanic populations for intervention deployment. Priority zones were then matched on population…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Community residents: Community residents may engage with various intervention components deployed in the intervention priority zones. * Community Physicians: may engage with various intervention components deployed in the intervention priority zones if they 1) practice medicine in one of the geographic priority zones. * Cancer Center Physicians: may engage with various intervention components if they 1) practice medicine at Moffitt. * Clinical Research Coordinators (CRC): may engage with various intervention components if they 1) work as a CRC at Moffitt and 2) coordinat…
Interventions
- BehavioralContinuing Medical Education Events (CME)
An engaging 1-hour informational session focusing on topic areas such as implicit bias and emerging evidence from recent cancer clinical trials with CME credit or American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) points available.
- BehavioralTrial Connect Portal
A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.
- BehavioralClinical Trial Newsletters
Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed by email/mail.
- BehavioralImplicit Bias Training
A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.
- BehavioralRecruitment Dashboard
A dynamic dashboard depicting the number of patients recruited to clinical trials by gender, race, ethnicity, age, cancer type, residence in the catchment area, and other key clinical characteristics.
- BehavioralPortfolio Profiler
An interactive dashboard to allow cancer center physicians easily identify gaps in the current clinical trial portfolio that may be contributing to racial/ethnic disparities in trial enrollment.
- BehavioralEligibility Calculator
A digital calculator that will allow for assessment of the potential impact of clinical trial eligibility criteria (e.g., comorbidities, age, lab values) that may disproportionately exclude patients who are Black and Hispanic prior to submission of clinical trial protocols to the Scientific Review Committee.
- BehavioralClinical Trial Education Sessions (Community Residents Only)
An engaging 1-hour educational session delivered by a community health educator that includes basic information about clinical trials, their importance, myths, need for diversity in the trials process, and resources for finding more information about clinical trials.
- BehavioralACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)
A study team member will be available for questions via a dedicated phone-line and email for community residents and Moffitt patients with a return contact within 24-hours.
- BehavioralNew Patient Information (Moffitt Patients Only)
Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.
- OtherNo Intervention
Control group with no intervention.
Location
- Moffitt Cancer CenterTampa, Florida